Suture leader

ABSTRACT

Methods and devices are provided for securing tissue to bone. In general, a suture leader can have leading and trailing ends, and an inner passageway configured to receive a strand of suture therein. More specifically, the trailing end of the leader can be configured to receive the strand of suture therein to form an overlapping region of suture leader and suture. When the suture is positioned in the leader, an outer diameter of the leading end of the leader can be less than an outer diameter of the over lapping region. The leader can have a lower bending stiffness than the suture so that the leader can be more easily folded into a bend. In certain aspects, the suture leader can be formed from a substantially flexible, braided material so that the leader can be configured to contract when a pulling force is applied to the leader. In another embodiment, the suture leader can have a pre-formed crease configured to mate with a threading tool.

FIELD

The present disclosure relates to devices and methods for attaching softtissue to bone.

BACKGROUND

The complete or partial detachment of ligaments, tendons and/or othersoft tissues from their associated bones within the body are relativelycommonplace injuries, particularly among athletes. Such injuries aregenerally the result of excessive stresses being placed on thesetissues. By way of example, tissue detachment may occur as the result ofan accident such as a fall, over-exertion during a work-relatedactivity, during the course of an athletic event, or in any one of manyother situations and/or activities. In the case of a partial detachment,the injury will frequently heal itself, if given sufficient time and ifcare is taken not to expose the injury to further undue stress. In thecase of complete detachment, however, surgery may be needed to re-attachthe soft tissue to its associated bone or bones.

Numerous devices are currently available to re-attach soft tissue tobone. Examples of such currently-available devices include screws,staples, suture anchors, and tacks. In soft tissue re-attachmentprocedures utilizing screws, the detached soft tissue is typically movedback into its original position over the bone. Then the screw is screwedthrough the soft tissue and into the bone, with the shank and head ofthe screw holding the soft tissue to the bone. Similarly, in soft tissuere-attachment procedures utilizing staples, the detached soft tissue istypically moved back into its original position over the bone. Then thestaple is driven through the soft tissue and into the bone, with thelegs and bridge of the staple holding the soft tissue to the bone.

In soft tissue re-attachment procedures utilizing suture anchors, ananchor-receiving hole is generally first drilled in the bone at thedesired point of tissue re-attachment. A suture anchor is then deployedin the hole using an appropriate installation tool. This effectivelylocks the suture, with soft tissue attached thereto.

While suture anchors provide an effective, minimally-invasive techniquefor soft tissue repair, it is desirable to utilize an anchor having asmall diameter so as to avoid unnecessary trauma. The size of theanchor, however, can be limited by the size of the suture and/or thebending stiffness of the suture. Typically, a single strand of repairsuture is folded and trailing ends of the suture are attached to athreader loop, which is used to pull the folded suture into the anchor.When a folded suture is used, the cannulated portion of the anchor mustbe large enough to accommodate at least two times the thickness of therepair suture. The bending stiffness of the repair suture used can alsolimit the size of the anchor. For example, high strength suture can havea greater bending stiffness than other types of suture and this can makeit difficult to bring legs of the suture together to form a 180° fold,especially near the location of the bend. Because a width at the bend islarger than a width of two legs of the suture, it can be difficult tofit the bend in a lumen in the anchor. This in turn restricts theability to reduce the size of the anchor.

Accordingly, there remains a need for improved methods and devices forattaching soft tissue to bone.

SUMMARY

Various surgical devices are provided herein. In one embodiment, asurgical device is provided that includes at least one suture strand anda biocompatible suture leader. The suture leader can have a firstterminal end portion that is mated to a terminal end portion of the atleast one suture strand. The suture leader can have an outer diameteralong at least a portion of a length thereof that is less than a maximumouter diameter of the at least one suture strand. The suture leader canfurther include a pre-formed crease therein such that the suture leaderis bent when it is in a resting state.

The device can vary in a number of ways. For example, the first terminalend portion of the suture leader can be configured to collapse aroundthe terminal end portion of the at least one suture strand when apulling force is applied to the suture leader. For another example, theterminal end portion of the at least one suture strand can be disposedwithin an inner passageway in the first terminal end portion of thesuture leader. The suture leader can further include a second terminalend portion having an outer diameter that is preferably less than onehalf an outer diameter of the at least one suture strand. In certainaspects, the suture leader can be detachably mated to the at least onesuture strand. The at least one suture strand can include a singlesuture strand having first and second terminal end portions that arereceived within the first terminal end portion of the suture leader. Inother aspects, the at least one suture strand can include first andsecond suture strands, and a first terminal end of the first suturestrand and a second terminal end of the second suture strand can bereceived in the first terminal end portion of the suture leader.

In another embodiment, a suture can include a first length ofbiocompatible suture strand and a first length of biocompatible sutureleader. The suture strand can have leading and trailing ends. The sutureleader can have a lumen extending at least partially therethrough andoriginating at a trailing end thereof. The suture leader can have anouter diameter along at least a portion thereof that is less than amaximum outer diameter of the first length of suture strand. The leadingend of the first length of suture can be disposed within the lumen inthe trailing end of the suture leader such that a force applied to aleading end of the suture leader causes the trailing end of the sutureleader to contract and engage the leading end of the suture strand.

The suture can vary in other ways. For example, the suture can include asecond length of biocompatible suture strand having a leading enddisposed within the lumen of the suture leader. The suture leader caninclude a pre-formed hook formed therein. The trailing end of the sutureleader can be configured to contract around the suture strand when atensile force is applied to the suture leader. In certain aspects, thesuture leader can have a braided structure. In other aspects, the sutureleader can have a color contrasted from a color of the suture strand tovisually distinguish the suture leader from the suture strand. Thesuture leader and the suture strand can be fixedly coupled at one ormore discrete locations.

A method for attaching tissue to bone is also provided, and can includethreading suture into a suture anchor. In one embodiment, the method caninclude positioning a threader loop within a crease pre-formed in asuture leader such that the suture leader is hooked onto the threaderloop, and pulling the threader loop to pull the suture leader through alumen in a suture anchor. The suture leader can have a suture attachedto a first trailing end thereof, and the suture leader can collapsearound the suture as the suture leader is pulled through the sutureanchor.

The surgical method can include a variety of modifications. For example,pulling the suture leader can cause at least a portion of the sutureleader to radially collapse around the suture. Pulling the threader loopcan include pulling the threader loop distally through the lumen, arounda suture-receiving member in the suture anchor, and proximally throughthe lumen. The surgical method can also include detaching the sutureleader from the suture strand after the suture leader is pulled throughthe suture anchor. Prior to pulling the threader loop through the sutureanchor, the threader loop can be positioned within a crease pre-formedin a second suture leader, the second suture leader being attached to asecond trailing end of the suture. Pulling the threader loop candecrease outer diameters of the first and second suture leaders suchthat the first and second suture leaders are dimensioned to pass throughan eyelet formed in the suture anchor. The suture leader can also have afirst suture and a second suture attached to the first trailing endthereof.

BRIEF DESCRIPTION OF DRAWINGS

This invention will be more fully understood from the following detaileddescription taken in conjunction with the accompanying drawings, inwhich:

FIG. 1 is perspective, semi-transparent view of two suture leaders matedwith a suture, according to one exemplary embodiment;

FIG. 2A is a side view of the suture leader of FIG. 1;

FIG. 2B is a cross-sectional view of the suture leader of FIG. 2A, takenalong an axis perpendicular to longitudinal axis L;

FIG. 3A is another embodiment of a suture leader having a bent terminalend portion;

FIG. 3B is another embodiment of a suture leader having a curvedterminal end portion;

FIG. 4A is a perspective view of an exemplary suture configured to bereceived within a suture leader;

FIG. 4B is a cross-sectional view of the suture of FIG. 4A;

FIG. 5A is a partially transparent, side view of the suture leader andsuture of FIG. 1, showing the overlapping region of suture leader andsuture;

FIG. 5B is a partially transparent, side view of the suture leader ofFIG. 1 having first and second terminal ends of suture received therein;

FIG. 5C is a partially transparent, side view of the suture leader andsuture of FIG. 1, showing a plurality of fixation points;

FIG. 6 is a perspective view of a suture in a folded configuration witha wide bent portion compared with the width near the first and secondends;

FIG. 7 is a cross-sectional view of one embodiment of an anchorconfigured to receive the suture leader and strand of suture of FIG. 1therein;

FIG. 8 is a perspective view of the suture leader of FIG. 3A having afirst end mated to a threader loop;

FIG. 9 is a cross-sectional view of the anchor of FIG. 7 with a threaderloop extending therethrough and mated with bent terminal ends of twosuture leaders;

FIG. 10 is a perspective view of the suture leaders and threader of FIG.9 being pulled through an eyelet of an anchor;

FIG. 11 is a cross-sectional view of the anchor of FIG. 7 with thesuture leader of FIG. 3A threaded within the anchor; and

FIG. 12 is a cross-sectional view of the anchor of FIG. 11 with thesuture threaded completely through the anchor and the leaders positionedoutside of the anchor.

DETAILED DESCRIPTION

Certain exemplary embodiments will now be described to provide anoverall understanding of the principles of the structure, function,manufacture, and use of the devices and methods disclosed herein. One ormore examples of these embodiments are illustrated in the accompanyingdrawings. Those skilled in the art will understand that the devices andmethods specifically described herein and illustrated in theaccompanying drawings are non-limiting exemplary embodiments and thatthe scope of the present invention is defined solely by the claims. Thefeatures illustrated or described in connection with one exemplaryembodiment may be combined with the features of other embodiments. Suchmodifications and variations are intended to be included within thescope of the present invention. Further, in the present disclosure,like-numbered components of the embodiments generally have similarfeatures, and thus within a particular embodiment each feature of eachlike-numbered component is not necessarily fully elaborated upon.Additionally, to the extent that linear or circular dimensions are usedin the description of the disclosed systems, devices, and methods, suchdimensions are not intended to limit the types of shapes that can beused in conjunction with such systems, devices, and methods. A personskilled in the art will recognize that an equivalent to such linear andcircular dimensions can easily be determined for any geometric shape.Sizes and shapes of the systems and devices, and the components thereof,can depend at least on the anatomy of the subject in which the systemsand devices will be used, the size and shape of components with whichthe systems and devices will be used, and the methods and procedures inwhich the systems and devices will be used.

The figures provided herein are not necessarily to scale. Still further,to the extent arrows are used to describe a direction a component can betensioned or pulled, these arrows are illustrative and in no way limitthe direction the respective component can be tensioned or pulled. Aperson skilled in the art will recognize other ways and directions forcreating the desired tension. Likewise, while in some embodimentsmovement of one component is described with respect to another, a personskilled in the art will recognize that other movements are possible.Additionally, a number of terms may be used throughout the disclosureinterchangeably but will be understood by a person skilled in the art.

Various devices and methods are provided for threading a suture througha suture anchor, and for anchoring suture to bone. In general, thepresent invention provides a suture leader that is configured to matewith an end of at least one suture, and that can facilitate loading ofat least one suture onto a suture anchor. For example, in one embodimentthe suture leader can have an inner passageway sized to receive one ormore ends of one or more sutures. In certain aspects, a leading end ofthe leader can include a bent or hooked end portion that is configuredto mate with a suture threading tool, such as a threader loop. In use,the suture leader can be mated to one or more sutures, and the leadercan be folded around or hooked onto the threading tool. Because theleader can have a low bending stiffness relative to the bendingstiffness of the suture(s), the folded leader can have a smaller widthnear the bend than if the suture were directly folded around thethreader and then pulled through the anchor. Alternatively, the hookedend of the suture leader can provide a reduced-width region, as comparedto a bent suture, that facilitates passage through an anchor. A pullingforce can be applied to the suture leader to cause an overlapping regionof the leader to contract around the suture(s) and provide a smoothtransition between the suture(s) and the leader. The leader can guidethe suture through the anchor until the suture is threaded completelythrough the anchor and the leader is positioned outside of the anchor.In one embodiment, the suture leader can be detached from the suture(s)after the suture(s) has been threaded onto the anchor, such as bysliding the suture leader off the suture(s).

FIG. 1 illustrates an exemplary embodiment of first and second sutureleaders 100, 100′ mated to first and second ends of a single strand ofsuture 10. Though reference is made to suture leader 100, suture leader100′ can have the same features. In general, the suture leader 100 canhave an elongate shape and can have first and second terminal ends 100a, 100 b. The suture leader 100 can also have an inner passageway 102extending through all or a portion thereof for receiving one of moreends of a suture, such as a first end 10 a of the suture 10. Thefirst/leading end 100 a of the suture leader can facilitate loading ofthe suture 10 onto an anchor (not shown) by leading the suture 10 intothe anchor, as will be discussed in greater detail below. A personskilled in the art will appreciate that the suture leader can beconfigured to mate to or receive any number of ends of one or moresutures.

The suture leader 100 can have various sizes, shapes, andconfigurations. FIG. 2A illustrates the suture leader 100 without asuture disposed therein. As shown, the suture leader 100 can have asubstantially cylindrical shape with the inner passageway 102 extendingalong a longitudinal axis L thereof. The inner passageway 102 can extendalong a portion of the suture leader 100 or along an entire length ofthe leader 100, but preferably the inner passageway 102 originates at aterminal end portion of the leader 100, e.g., at terminal end 100 a asshown. A person skilled in the art will appreciate that the sutureleader can have other cross-sectional shapes, such as ovular, square,rectangular, etc. FIG. 2B is a cross-sectional view of the suture leader100 and shows an inner diameter D_(i), an outer diameter D_(o), and awall thickness W. In general, the suture leader 100 can have arelatively thin wall thickness W such that when a suture is disposedtherein, the outer diameter of the suture leader along the regionoverlapping the suture is smaller than twice a diameter of the suture itreceives. That is, the wall thickness W should be thin enough so that ofthe suture plus two times the added wall thickness W from the sutureleader 100 is still be smaller than a width of a folded suture 10, aswill be discussed below. A length of the suture leader L₁ can beselected based on the particular surgical procedure to be performed, butin one embodiment the length L₁ can be in the range of about 70 mm to250, such as about 200 mm, as measured from terminal end to terminal endwhen the suture leader 100 is in a linear configuration.

The suture leader 100 can have various mechanical properties that canfacilitate use of the suture leader for loading a suture onto a sutureanchor. In one embodiment, the suture leader 100 can be relatively stiffalong its length, but bendable to allow for ease of threading the leader100 through a bone anchor. In another embodiment, the suture leader 100can be substantially flexible along its length. The manufacturingtechniques and/or the material(s) used can be selected to achieve adesired flexibility. By way of non-limiting example, such material caninclude high molecular weight polyethylene, polyester, polyethyleneterephthalate (PET), polyether ether ketone (PEEK), or a blend of anycombination of these materials. During manufacturing, filaments and/orfibers can be braided, twisted, and/or weaved together to form a leaderhaving an inner passageway, also referred to as a hollow core. Forexample, FIG. 2A illustrates the suture leader 100 with a woven orbraided structure and having the inner passageway extending through itsentire length L₁. In another embodiment, a first portion of the sutureleader can have a braided structure with the hollow core/innerpassageway extending therethrough, and a second portion of the leadercan be substantially solid. Alternatively, the suture leader can beformed from a solid material, and the core of the suture leader can bepartially or entirely removed. By way of non-limiting example, thesuture leader can be formed from commercially available suture, such asETHIBOND #0 manufactured by Ethicon, Inc. of Somerville, N.J.

The suture leader can have a variety of other features. Anotherembodiment of a suture leader 200 is illustrated in FIG. 3A. As shown,an end portion of the suture leader 200 can have an engagement feature,such as a pre-formed hook, to facilitate engagement to a suture or athreader loop. Various techniques can be used to form the hook. By wayof non-limiting example, the suture leader can include a fold or creaseformed therein such that when the suture leader 200 is in a restingconfiguration, the end of the suture leader can be bent or hooked. Inparticular, a terminal end 200 a of the suture leader 200 can beangularly offset from a longitudinal axis L₂ of the suture leader 200 byan angle θ so that the leader 200 can be hooked onto a threader (notshown). By way of non-limiting example, the angle θ can be in the rangeof about 0-90°. As will be appreciated by a person skilled in the art,the crease 204 can be formed at various locations on the suture leader200. The location of the crease 204 relative to the terminal end 200 aof the leader 200 can be at a distance that ensures that the end canhook onto a threader. For example, the crease can be at a position suchthat the end portion has a length L_(C) that can be in the range ofabout 12 mm to 100 mm and a body of the leader can have a length L_(B)that can be in the range of about 25 mm to 300 mm.

The crease 204 can be formed using various manufacturing techniques,such as compression or heat setting or by applying biocompatible glueand/or other bonding material known in the art, or by other techniques,either separately or in combination. Thus, the crease 204 can be madestrong enough to substantially maintain its shape when it is passedthrough tissue.

In another embodiment shown in FIG. 3B, a suture leader 300 can have aterminal end that is curved or has a J-shaped hook. For example, theleader 300 can have a curved terminal end portion 302, rather than asharp bend or crease. The terminal end portion 302 of the leader 300 canbe spaced at a distance away from a body 304 of the leader 300 to definea height H. The leader 300 can be formed from a solid material, such asmonofilament suture, that can substantially retain its shape even whenthe leader 300 is passed through tissue.

Leaders 100, 200, and 300 can be used with any suture and with anynumber of sutures. While the suture 10 can have various sizes, shapes,and configurations, FIG. 4A illustrates one embodiment of a suture 10that includes the first and second terminal ends 10 a, 10 b with alength L_(S) therebetween. The suture 10 can have a length L_(S) suchthat it can be threaded through tissue and through a bone anchor, withterminal ends extending from the bone anchor. The suture 10 can have anouter diameter D_(S), as shown in FIG. 4B that can vary. By way ofnon-limiting example, the outer diameter D_(S) of the suture 10 can bein the range of about 0.15 mm to 0.7 mm, and preferably about 0.5 mm to0.6 mm. This corresponds to sutures ranging from size #4-0 to size #5,and preferably size #2. The suture 10 can include an inner passageway(not shown) extending along a longitudinal axis of the suture 10, or asin the illustrated embodiment, the suture 10 can be substantially solidalong its length L_(S). The suture 10 can be formed from a biocompatiblematerial, and the material can be absorbable, partially-absorbable, ornon-absorbable depending on the particular surgical procedure. Forexample, non-absorbable suture can be used in surgical procedures thatrequire a strong amount of fixation in order to maintain contact betweentissue and adjacent bone. By way of non-limiting example, the suture 10can be a high strength suture, such as ORTHOCORD #2 manufactured byEthicon, Inc. of Somerville, N.J.

The suture 10 and suture leader 100 can have other features. Thoughreference is made to suture leader 100, suture leaders 200, 300 can haveany combination of the features described herein. In one embodiment, thesuture 10 and leader 100 can be visually distinct. For example, thesuture 10 can be formed from a first color and the leader 100 can beformed from a second color to help a user visually identify the end ofan overlapping region of the leader 100 from the suture 10. This can beaccomplished by dying or otherwise marking the suture 10 and/or thesuture leading 100 during manufacturing. Alternatively, the suture andsuture leader can each be braided from filaments of differing color,and/or using different pick counts to produce distinct patterns.Non-limiting examples of sutures having different pick counts arediscussed in U.S. patent application Ser. No. 13/623,467, filed on evendate herewith and entitled “Methods and Devices for Threading Sutures,”which is hereby incorporated by reference in its entirety.

In use, the first end 10 a of the suture 10 can be received in thetrailing, second end 100 b of the suture leader 100 to form anoverlapping region R, as shown in FIG. 5A. The overlapping region R canhave any length, such as a length in the range of about 50 mm to 160 mm,to ensure sufficient contact between the suture 10 and the suture leader100. The relative diameters of the suture, the leader, and theoverlapping region can vary, and the relative sizing can apply to theleaders 100, 200, and 300. When the suture 10 is positioned in theleader 100, as shown in FIG. 5A, the outer diameter D_(R) of theoverlapping region R is defined by the outer diameter D_(S) of thesuture 10 plus twice the wall thickness W of the suture leader 100. Inone embodiment, the outer diameter D_(R) of the overlapping region R canbe slightly larger than the outer diameter D_(S) of the strand of suture10. Preferably, the outer diameter D_(R) of the overlapping region isless than twice the diameter D_(S) of the suture. As shown, the outerdiameter D_(o) of the leading end 100 a of the leader can be equal to orsmaller than the outer diameter D_(S) of the suture strand 10. Morepreferably, the outer diameter D_(o) of the leading end 100 a is lessthan half the outer diameter D_(R) of the overlapping region R. In thisway, the reduced diameter of the leading end 100 a can counteract theadded wall thickness W in the overlapping region R.

The suture 10 can be positioned within the leader 100 using varioustechniques. Referring back to FIG. 2A, when the suture leader 100 doesnot have a suture disposed therein, the leader 100 can have an innerdiameter that can be substantially constant along its length L₁. Asshown in FIG. 5A, when the leader 100 has the suture 10 positionedtherein, the leader 100 can have inner diameter D_(i), at the leadingend 100 a that is less than the outer diameter D_(S) of the suture 10.Accordingly, the inner diameter of the leader 100 can thus be expandedat the overlapping region R, such as by compressing the leader 100 in alongitudinal direction, so that the leader 100 can be sized to receivethe suture therein. This can expand the outer diameter of the leader 100such that the diameter D_(R) of the leader 100 at the trailing, secondend 100 b is greater than the outer diameter D_(o) at the leading, firstend 100 a. Typically, the suture 10 can be mated with the leader 100during the manufacturing process by sliding the suture 10 into the lumenin the trailing end 100 b of the leader 100.

While FIG. 5A illustrates a suture leader having a single strand ofsuture therein, a person skilled in the art will appreciate that thesuture leader can be configured to receive any number of suture strandstherein. By way of example, FIG. 5B illustrates first and secondterminal ends 11 a, 11 b of suture disposed within and mated to sutureleader 100. The terminal ends 11 a, 11 b can be ends of the same suture,or ends of two different sutures. While not shown, a folded portion ofone or more sutures can also be received in the suture leader.

In general, the suture leader 100 and the suture 10 can be temporarilyor permanently mated together using various techniques. For example, inone embodiment the suture leader 100 can radially contract or compressaround an outer circumference of the suture 10 when an axial pullingforce is applied to the suture leader. This can prevent the suture 10from unintentionally being pulled out from the suture leader 100. Whentension is applied to the leader 100 by pulling on the leading end 100 aof the leader, the braided configuration of the leader 100 will bepulled axially, thus tightening the braid and increasing the contractingforce around the suture 10. The leader 100 can function as a Chinesefinger trap in that the applied tension can both increase a length ofthe leader and decrease inner and outer diameters of the leader 100. Inanother embodiment, the mating between the suture leader 100 and thesuture 10 can be supplemented at one on more discrete locations alongthe overlapping region. For example, FIG. 5C depicts the leader 100 andsuture 10 with evenly spaced fixation points F₁, F₂, and F₃. Thefixation points F₁, F₂, and F₃ can be made using various techniquesknown in the art, such as heat treatment, spot welds, etc, and anynumber of fixation points can be positioned at any location on theoverlapping region R. Additionally or alternatively, fibers or filamentsof the suture 10 and the leader 100 can be spliced together at variouslocations to form temporary or permanent fixation points.

As previously mentioned, the bending stiffness of a suture can make itdifficult to thread a suture onto an anchor. FIG. 6 illustrates oneexample of this concept, showing the suture 10 in a foldedconfiguration. Because the suture 10 can have a high bending stiffness,opposed sides of the suture cannot be brought together to form a 180°fold. Rather, a folded portion F of the suture 10 has a width W_(F) thatis greater than a combined width Ws of the suture legs. Because thefolded portion F is typically pulled into an anchor before the first andsecond ends 10 a, 10 b, the suture 10 occupies a larger space than if itcould achieve the 180° fold. A leader can thus be used in combinationwith the suture 10 to avoid the need to fold the suture for threading itinto the anchor, as will be discussed.

FIG. 7 illustrates one exemplary embodiment of a cannulated sutureanchor 20 for anchoring tissue to bone. As shown, the suture anchor 20is in the form of a generally elongate body having proximal and distalends 20 p, 20 d with an inner lumen 22 extending therethrough. In oneembodiment, the inner lumen 22 can have a substantially cylindricalshape defining an inner diameter D_(L). At least one bone-engagingsurface feature 24 can be formed on at least a portion of an externalsurface thereof for engaging bone. The suture anchor 20 can also includea suture-receiving member 26 disposed within the inner lumen 22 adjacentto the distal end 20 d of the suture anchor 20. The suture-receivingmember 26 is adapted to receive one or more sutures therearound suchthat the suture(s) can extend around the suture-receiving member 26 andtrailing ends of the suture(s) can extend through the inner lumen 22 andout of the proximal end 20 p of the suture anchor 20.

The body of the suture anchor 20 can have a variety of configurations,shapes, and sizes. In an exemplary embodiment, the anchor 20 isconfigured to be implanted within a bone tunnel formed in bone, and morepreferably it has a size and shape that allows it to be fully engagedthrough the thickness of the cortical bone. In the illustratedembodiment the body has a generally elongate cylindrical shape with ablunt or rounded distal end 20 d to facilitate introduction of theanchor 20 into a bone tunnel. The proximal end 20 p of the body can behead-free, and the cannulated body can be configured to allow a driverto be inserted into the inner lumen to drive the suture anchor intobone. In another embodiment, the proximal end 20 p of the body can havea head for mating with a driver for driving the anchor 20 into bone. Asindicated above, the suture anchor 20 can also include one or morebone-engaging surface features 24 formed thereon and adapted to engagebone. While various surface features can be used, such as teeth, ridges,protrusions, etc., in an exemplary embodiment the body can include oneor more threads extending therearound.

As previously indicated above, the suture anchor 20 can also include asuture-receiving member formed therein. The suture-receiving member 26can have a variety of configurations, but in an exemplary embodiment itis adapted to seat one or more sutures that extend through the innerlumen 22 of the anchor 20. As shown in FIG. 7, the suture-receivingmember 26 is in the form of a post that extends transversely across theinner lumen 22 and between opposed inner sidewalls 28, 30 of the sutureanchor. The angular orientation of the suture-receiving member 26relative to a longitudinal axis L_(A) of the inner lumen 22 can vary,but in an exemplary embodiment the suture-receiving member 26 extendssubstantially perpendicular to the longitudinal axis L_(A) of the innerlumen 22. The location of the suture-receiving member 26 can also vary,but in an exemplary embodiment the suture-receiving member 26 ispositioned at or adjacent to the distal end 20 d of the suture anchor20. In the embodiment shown in FIG. 7 the suture-receiving member 26 islocated just proximal to the distal-most end 20 d of the suture anchor20 so as to form a suture-seating groove in the distal-most end 20 d ofthe suture anchor 20. This recessed configuration of thesuture-receiving member 26 can allow a suture(s) disposed around thesuture-receiving member 26 to sit flush or sub-flush with the distal end20 d of the suture anchor 20 such that the suture(s) will not interferewith insertion of the suture anchor 20 into bone. A person skilled inthe art will appreciate that the suture-receiving member can beintegrally formed with the suture anchor, i.e., the suture anchor andsuture-receiving member can be molded as a single unit or formed from asingle piece of material, or the suture-receiving member can be fixedlyor removably mated to the suture anchor. Additionally, thesuture-receiving member can have other configurations, such as an eyeletthat can receive the suture 10 and leader 100 therethrough. Non-limitingexamples of suture anchors and deploying suture anchors into bone aredescribed in further detail in U.S. application Ser. No. 11/555,545entitled “Cannulated Suture Anchor” filed Feb. 1, 2006, now U.S. Pat.No. 8,114,128, U.S. application Ser. No. 11/855,670 entitled “DualThread Cannulated Suture Anchor” filed Sep. 14, 2007, U.S. applicationSer. No. 10/615,625 entitled “Bioabsorbable Suture Anchor System For UseIn Small Joints” filed Jun. 27, 2003, now U.S. Pat. No. 8,133,257, U.S.patent application Ser. No. 13/623,258, filed on even date herewith andentitled “Anti-Backup Suture Anchor,”, and U.S. patent application Ser.No. 13/623,449, filed on even date herewith and entitled “Self-CinchingSuture Anchors, and Methods,”, all which are hereby incorporated byreference in their entireties.

The devices described above can be used to perform a surgical procedurefor attaching tissue to bone, e.g. anterior cruciate ligament (ACL)repair, rotator cuff repair, etc. In an exemplary embodiment, aprocedure including implantation of the anchor can be a minimallyinvasive procedure, but as will be appreciated by a person skilled inthe art, the implants discussed herein also have application in opensurgical instrumentation as well as application in robotic-assistedsurgery. Though reference is made to suture 10 and suture leader 100,the devices shown are exemplary and the method can be performed with anynumber and any embodiment of a suture and a leader. For example, whilesome of the embodiments show a single suture leader mated with oneterminal end of the suture, first and second ends of the suture can eachhave a different suture leader mated thereto or first and second ends ofthe same or different sutures can be disposed within a single leader.Additionally, the suture leader 100 can be substituted or interchangedwith the suture leaders 200, 300 described above.

As one skilled in the art will appreciate, the procedure usually beginsby preparing the patient for surgery and making one or moreappropriately sized incisions at a desired location. In a minimallyinvasive procedure, one or more cannulas can be positioned in theincisions to provide access to the surgical site. One skilled in the artwill also understand that one or more viewing devices, e.g., scopes, canbe placed in one of the incisions to allow medical personnel to view thesurgical site from outside the body.

Once the patient is prepared for surgery, a length of suture 10 can beinserted into the patient's body and through tissue to be surgicallyreattached to bone. When a combination suture and suture leader is used,the leading end of the suture leader can be inserted through the tissuedirectly using a tool, such as a needle. The leader can be used to pullthe suture coupled thereto through the tissue. Alternatively, the suturecan be threaded through the tissue and then coupled to the sutureleader, e.g., by passing the leading end of the suture into the lumen inthe trailing end of the suture leader. One skilled in the art willappreciate that the suture and/or leader can be passed through thetissue using any known surgical technique, such as by mattress and cinchloop methods. With the suture and leader so positioned, a bore, bonehole, or bone tunnel, generally referred to herein as a “bone hole,” canbe formed in bone of the patient. The bone hole can be pre-formed, suchas by using a drill, an awl, a punch instrument, etc., as will beappreciated by a person skilled in the art. Alternatively, the bone holecan be formed simultaneously with advancement of a suture anchor intothe bone and simultaneously with threadable engagement of the anchortherewith, such as by using a self-awling or self-tapping driver and/orself-awling or self-tapping anchor. The bone hole can extend fullythrough cortical bone to allow the suture anchor to be fully engagedthrough the thickness of the cortical bone. The bone tunnel can alsoextend into cancellous bone located underneath the cortical bone. Thesuture anchor can be deployed in the bone hole before or after sutureleader is threaded or loaded onto the suture anchor. With the sutureand/or leader(s) threaded through tissue, the terminal ends can extendoutside of the body. The suture and the leader can be threaded onto theanchor, either before or after the anchor is implanted in bone.

The suture 10 and leader 100 can be threaded through the anchor 20 invarious ways and using various tools known in the art, such as athreader loop. As shown in FIG. 8, in general, the leader 100 can bebent into a 180° fold prior to being pulled through a lumen in a sutureanchor, and the leader 100 can guide the suture therethrough. This caneliminate the need to fold the suture and pull the folded portion of thesuture through the lumen of the anchor. In particular, when the sutureleader 200 includes the pre-formed crease 204, the end portion of theleader 200 can be hooked onto a head portion 42 of the threader loop 40prior to threading the leader 200 and the suture coupled thereto throughthe anchor. The leader 200 can be mated to the threader loop 40 in otherways, such as using a knot, glue, or other known engagement techniques.In another embodiment, shown in FIG. 9, when two suture leaders 200,200′ are coupled to a single strand of suture, the two suture leaders200, 200′ can be mated with a single threader loop 40. When the threaderloop 40 or other threading tool is used, the threader loop 40 can bepre-disposed within the suture anchor 20 such that leading and trailingends of the threader 40 extend from the proximal end 20 p of the anchor20. This allows the suture leader(s) 200, 200′ to be hooked onto thehead of the threader 40 and then simply pulled through the anchor 20.More specifically, during loading of the threader loop 40 onto theanchor 20, the threader loop 40 can extend distally through thecannulated portion of the anchor 20 and can be wrapped around or extendthrough the suture-receiving member 26, and can extend proximally backthrough the lumen and out of the proximal end of the anchor 20. Athreader loop 40 loaded onto the anchor 20 is shown in FIG. 9, alongwith the suture leaders 200, 200′ mated with first and second ends of asuture strand 10. In use, a pulling force can be applied to the leadingend of the threader loop 40, which can pull the head 42 of the threader40 (which is trailing) through the lumen of the anchor 20. The pullingforce can cause the suture leaders 200, 200′ to radially contract aroundthe suture 10. The pulling force applied to the threader loop 40 canpull the first and second suture leaders 200, 200′ through the lumen 22of the anchor 20. As shown in FIG. 10, where the suture-receiving member26 is an eyelet, the threader loop 40 can be pulled therethrough, alongwith the suture leaders 200, 200′. The applied pulling force can causethe suture leaders 200, 200′ to radially contract around the suture 10so that the leaders 200, 200′ are sized to pass through the eyelet 26.

FIG. 11 shows the leaders 200, 200′ and the suture 10 being threadedthrough the anchor 20. The leading ends of the leaders 200, 200′ can bepartially inserted through the anchor 20 and a pulling or tensioningforce T₁ can be applied, such as using the threader loop. The leaders200, 200′ can have a length such that they can extend substantiallythrough the inner lumen 22 of the anchor 22, as shown, or in otherembodiments the leaders 200, 200′ can extend partially through the lumen22. In embodiments where the leaders 200, 200′ are formed from a braidedmaterial, the leaders 200, 200′ can compress around the suture 10 in theoverlapping region R as the leaders are pulled. This can facilitatesecure engagement of the suture. Moreover, the smooth transition betweenthe leaders 200, 200′ and the suture 10 can prevent snagging of theleader 200 in the anchor 20, such as around the suture-receiving member26. Moreover, because the leaders 200, 200′ can be bent or hooked, theycan have a smaller width than a folded suture. This technique can thusprevent the need to fold the suture 10 and then pull the folded portionof the suture 10 through the lumen 22. Moreover, the relative diametersof the suture 10 and the leaders 200, 200′ can allow the pre-bentleaders 200, 200′ to more easily fit within the lumen 22 of the anchor20. As previously mentioned, the outer diameter of the overlappingregion can be less than two times the outer diameter of the strand ofsuture. The outer diameter of the leading end of the leader 200 can besmaller than the outer diameter of the suture strand 10, such as twotimes smaller. This can be advantageous when the suture leaders 200,200′ and the suture 10 are being threaded through the lumen 22 of theanchor 20, as shown. FIG. 12 shows the suture 10 threaded completelythrough the anchor 20 and the leaders positioned outside of the anchor,with the suture 10 extending around the suture-engaging member 26.Because the terminal ends 10 a, 10 b of the suture 10 are pulled throughthe anchor 20 using the leaders 200, 200′, it is possible to thread thesuture 10 around the suture-engaging member 26 while having a smalldiameter D_(L) lumen relative to the diameter of the suture 10. A personskilled in the art will appreciate that a single leader can be used topull multiple ends of one or more sutures.

In one embodiment, the leader 100 can be removed from the terminal end10 a of the suture 10 after the suture is threaded through a sutureanchor. Removal can be achieved in various ways, such as by relievingany tension applied and grasping the trailing and of the leader to slidethe leader off of the suture. Where the suture leader 100 and suture 10are fixed at one or more discrete locations, such as with welds, amanual force can be sufficient to break the bonds to allow the suture 10to be removed from the leader 100. Alternatively, the suture leader 100can be removed from the suture 10 by cutting the suture 10 at a locationdistal to the leader 100.

With the suture 10 threaded through the suture anchor 20, the sutureanchor 20 can be deployed into the bone using various techniques. Forexample, the suture anchor 20 can be positioned on a distal end of adriver, and the driver can be rotated to force the suture anchor throughthe bone, such as through the bone tunnel previously described. Thesuture 10 can be tensioned to draw the tissue toward the suture anchor20 either prior to, during, or subsequent to driving the suture anchor20 into the bone. When the suture anchor 20 is fully seated in the bone,it can extend at least through cortical bone or through cortical boneand cancellous bone. After the suture 10 is tensioned to pull the tissuetoward the bone, trailing ends of the suture can be tied off orotherwise secured to maintain contact between the tissue and the bone.

One skilled in the art will appreciate further features and advantagesof the invention based on the above-described embodiments. Accordingly,the invention is not to be limited by what has been particularly shownand described, except as indicated by the appended claims. Further,although the systems, devices, and methods provided for herein aregenerally directed to surgical techniques, at least some of the systems,devices, and methods can be used in applications outside of the surgicalfield. All publications and references cited herein are expresslyincorporated herein by reference in their entirety.

What is claimed is:
 1. A suture, comprising: at least one suture strand;and a biocompatible suture leader having a first terminal end portionthat is mated to a terminal end portion of the at least one suturestrand, the suture leader having an outer diameter along at least aportion of a length thereof that is less than a maximum outer diameterof the at least one suture strand, and the suture leader including apre-formed crease therein formed from an intersection of two linearportions such that the suture leader is bent in a resting state.
 2. Thesuture of claim 1, wherein the first terminal end portion of the sutureleader is configured to collapse around the terminal end portion of theat least one suture strand when a pulling force is applied to the sutureleader.
 3. The suture of claim 1, wherein the terminal end portion ofthe at least one suture strand is disposed within an inner passageway inthe first terminal end portion of the suture leader.
 4. The suture ofclaim 1, wherein the suture leader includes a second terminal endportion having an outer diameter that is less than one half an outerdiameter of the at least one suture strand.
 5. The suture of claim 1,wherein the suture leader is detachably mated to the suture strand. 6.The suture of claim 1, wherein the at least one suture strand comprisesa single suture strand having first and second terminal end portionsthat are received within the first terminal end portion of the sutureleader.
 7. The suture of claim 1, wherein the at least one suture strandcomprises first and second suture strands, and a first terminal end ofthe first suture strand and a second terminal end of the second suturestrand are received in the first terminal end portion of the sutureleader.
 8. A suture, comprising: a first length of biocompatible suturestrand having leading and trailing ends; and a biocompatible sutureleader having a lumen extending at least partially therethrough andoriginating at a trailing end thereof, the suture leader having an outerdiameter along at least a portion thereof that is less than a maximumouter diameter of the first length of suture strand; wherein the leadingend of the first length of suture is disposed within the lumen in thetrailing end of the suture leader such that a user can selectively applya force to a leading end of the suture leader to cause the trailing endof the suture leader to contract and engage the leading end of thesuture strand, and to freely slidably remove the leading end when nopulling force is applied to the suture leader.
 9. The suture of claim 8,further comprising a second length of biocompatible suture strand havinga leading end disposed within the lumen of the suture leader.
 10. Thesuture of claim 8, wherein the suture leader further comprises apre-formed hook therein.
 11. The suture of claim 8, wherein the trailingend of the suture leader is configured to contract around the suturestrand when a tensile force is applied to the suture leader.
 12. Thesuture of claim 8, wherein the suture leader comprises a braidedstructure.
 13. The suture of claim 8, wherein the suture leader has acolor contrasted from a color of the suture strand to visuallydistinguish the suture leader from the suture strand.
 14. The suture ofclaim 8, wherein the suture leader and the suture strand are fixedlycoupled at one or more discrete locations.